Raffaella’s Literature Update

The following message is courtesy of Dr Raffaella Ravinetto, Public Health Department, Institute of Tropical Medicine Antwerp, Belgium. Ref. WHO Expert Committee on Specifications for Pharmaceutical Preparations: fifty-eight report. Geneva: World Health Organization; 2025 (WHO Technical Report Series, No. 1060). Licence: CC BY-NC-SA 3.0 IGO. Dear friends, The WHO has just published the 58th report of the Expert Committee ...

WHO Finalizes Landmark Pandemic Treaty

Final stretch at the World Health Organisation: a historic pandemic agreement is within reach! After more than 3 years of negotiations, member states are finalising today a crucial treaty to ensure a fairer and more equitable response to future pandemics. Despite compromises, the agreement marks major progress by putting equitable access to treatments and technologies ...

WHO Issues Alert on Falsified OXYCONTIN 80mg in Europe

The World Health Organization (WHO) has issued a Medical Product Alert for falsified OXYCONTIN 80mg (oxycodone hydrochloride) found in Switzerland. Laboratory testing revealed that the counterfeit tablets contain potent synthetic opioids, likely nitazene compounds, instead of oxycodone, posing a high risk of overdose and death. The falsified product mimics genuine MUNDIPHARMA-manufactured OXYCONTIN from Poland but features incorrect batch and ...

Senegal and Rwanda achieve WHO Maturity Level 3 in medicines regulation.

Quamed would like to congratulate the ARP in Senegal and the RFDA in Rwanda on this major achievement. We have seen firsthand how hard they have worked and how much they have accomplished over the past years. Another milestone achieved related to increased access to quality medicines! https://www.who.int/news/item/05-12-2024-senegal-and-rwanda-achieve-who-maturity-level-3-in-medicines-regulation

Boost Your QA Skills: WHO GSDP Course Now FIP-Approved

We are delighted to announce that our “Implementing the WHO GSDP and MQAS Guidelines” course has been awarded the FIP Seal. You can read about our courses on the International Pharmaceutical Federation (FIP) microsite here. The course is accessible on the QUAMED Learning Platform (learning.quamed.org). The course will expand your expertise on pharmaceutical quality assurance. ...

Setting the Standard: QUAMED’s QCP Gains Momentum in the Pharmaceutical Sector

Quamed launched its Quality Certification Programme (QCP) in early 2023, generating significant interest across the sector. To date, 63 organizations have expressed interest in pursuing QCP certification, with 32 submitting formal applications. Eight organizations have successfully obtained QCP certificates, while six more are progressing through the certification process. These numbers reflect both strong market interest ...

WHO Issues Urgent Alert on Falsified OZEMPIC in Brazil, UK, and USA

The World Health Organization (WHO) has issued an urgent alert about falsified OZEMPIC (semaglutide) detected in Brazil, the UK, and the USA. These counterfeit products pose significant health risks, including ineffective treatment and potential contamination. Identified batches include LP6F832, NAR0074 with serial number 430834149057, and falsified versions of genuine batch MP5E511. The public is advised ...

Congratulations to MCAZ for Achieving WHO Maturity Level 3

We would like to congratulate the MCAZ on becoming the 6th country in Africa to achieve WHO maturity level 3. We are indirectly profiting from their expertise as our colleague Linda Mudyiwenyama was part of the MCAZ team up to two years ago. Linda is currently collaborating with the Rwanda FDA in their quest to ...

Job Alert: Regulatory Expert

QUAMED (www.quamed.org) is a not-for-profit organisation specialising in various aspects of pharmaceutical quality assurance. We conduct pharmaceutical assessments and audits, develop and facilitate training courses around pharmaceutical quality, auditing and inspection and organise and provide technical assistance in the field of pharmaceutical quality assurance. We are starting a new project in Senegal with as objective ...

WHO Approves 33 New Regulatory Authorities

On Monday 20th of May 2024, the WHO approved 33 national and regional regulatory authorities, including the U.S. FDA and the European Medicines Regulatory Network (EMRN), as WHO Listed Authorities (WLAs), bringing the total to 36 WLAs from 34 Member States since March 2022. This milestone enhances global cooperation and regulatory standards for medicine and vaccine ...

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